TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ZIDOVUDINE (AZT) IN CHILDREN

评估齐多夫定 (AZT) 对儿童的安全性和有效性的试验

• 批准号: 3848411
• 负责人: NANCY HUTTON
• 金额: --
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3848411
• 关键词: AIDS therapy; HIV infections; child (0-11); clinical trials; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; nervous system disorder; pathologic process; pediatric AIDS; zidovudine

This is a Phase III trial of high versus low dose zidovudine administered to children with symptomatic HIV infection. Treatment will continue until the last patient enrolled has received 104 weeks, and direct assessments will be made for tolerance and side effects of the two regimens, for the progression of HIV infection, and for the degree of change in neurodevelopmental disease. Comparisons will be made between groups for clinical, immunological, and virological parameters.

这是一项III期临床试验， 给有症状的艾滋病毒感染儿童服用。 治疗 将继续 直到最后一名入选患者接受了104次治疗 周，直接 将对容忍度和侧面进行评估， 对两 治疗方案，针对艾滋病毒的进展 感染，以及 神经发育变化 疾病 将在以下方面进行比较： 用于临床的组， 免疫学和病毒学参数。